Economic Evaluation of Robot-assisted Laparoscopic Radical Prostatectomy vs Conventional Laparoscopic Radical Prostatectomy and Open Retropubic Radical Prostatectomy in Prostate Cancer: a Real-life Study Based on the French National Healthcare Data System (SNDS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

84667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cost Efficacy Evaluation of Robot Assisted Radical Prostatectomy

NCT02784314

Prostate Cancer

COMPLETED NA

Medico-economic Comparison of Robot-assisted Radical Prostatectomy Versus Radical Prostatectomy Via Laparotomy

NCT01577836

Prostatic Neoplasms

COMPLETED NA

Study of Robot-assisted Radical Prostatectomy Performed on Outpatient in Patients With Localized Prostate Cancer

NCT04319146

Prostate Cancer

ACTIVE_NOT_RECRUITING NA

Comparison of Radical Prostatectomy Performed by Robot-assisted Laparoscopy or Conventional Laparoscopy or by Laparotomy

NCT04638088

Prostate Cancer

RECRUITING

Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed as an Outpatient Versus an Inpatient Procedure.

NCT06822452

Prostate Cancer Surgery Ambulatory Care Outpatient Surgery

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Over the last 15 years, robot-assisted laparoscopic radical prostatectomy surgery has seen a considerable rise in France. To date, it represents the most common surgical technique for radical prostatectomies, compared with standard procedure such as open retropubic radical prostatectomy or laparoscopic radical prostatectomy (8000 procedures/year, 40% of surgeries). In 2016, the French Health Authority (HAS) published a report on the robot-assisted laparoscopic radical prostatectomy practice that highlighted the small amount of available convincing data to provide evidence for a significant clinical benefit. There were no published data on overall or progression-free survival compared with other surgical procedures, with an important organizational and financial impact for healthcare institutions and patients. The question of the clinical benefit and the cost-effectiveness ratio of this surgical procedure is still relevant taking into account that randomized studies are difficult to carry out and that results of prospective registers will be available in many years. In this context, the use of the French National Claims Database (SNDS) appears to be the best short-term and reduced-cost solution to identify patients who benefited from the three surgical procedures since the rise of robotics. It would provide real-life data to national institutions in order to conclude on the opportunity to set a specific hospital tariff for the robot-assisted laparoscopic radical prostatectomy. This study aims to assess the cost-effectiveness ratio and the clinical benefit (survival, disease recurrence, functional results) of the robot-assisted laparoscopic radical prostatectomy compared with other procedures using real-life data from SNDS. The population of patients who benefited from robot-assisted surgery will be identified in the SNDS through a practices survey, allowing the identification of centres fully converted to robotics.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with robot-assisted laparoscopic radical prostatectomy

No interventions assigned to this group

Patients with open retropubic radical prostatectomy

No interventions assigned to this group

Patients with laparoscopic radical prostatectomy

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Total retro-pubic prostatectomy (PTRP) identified in the SNDS by the standard, Classification of Medical Acts "JGFA006" act

* Laparoscopic total prostatectomy (PTL) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers not equipped with a surgical robot
* Robot-assisted total prostatectomy (PTRA) identified in the SNDS by the CCAM "JGFC001" act and the health and social establishment files number of centers equipped with a surgical robot for more than 12 months and having a rate of use of this technique for more than 95% minimally invasive prostatectomies. The number of PTRA will be identified by a survey in each center and the manufacturer's data as explained above

Patient who has not received previous treatment for this cancer by hormone therapy, radiotherapy, brachytherapy or HiFU (treatments sought in the SNDS prior to surgery by the prescription of pharmaceutical specialties or the presence of CCAM procedures)

Exclusion Criteria

* Patient operated for laparoscopic radical prostatectomy or robot-assisted laparoscopic radical prostatectomy in a center equipped with a surgical robot but with a rate of use of this technique less than 95% (centers offering different minimally invasive approaches that do not allow to define if the intervention was performed in robotic surgery or in open surgery)
* Patient operated for a robot-assisted laparoscopic radical prostatectomy in a center having started a robotic activity for less than 12 months

Patient previously treated with another therapeutic modality for his prostate cancer (salvage prostatectomies after hormone therapy, radiotherapy, brachytherapy or HiFU)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No